Test materials in short supply

India is facing an acute shortage of laboratory reagents to test for potentially deadly immunity reactions erupting in some covid-19 patients, leaving doctors to rely on chest scans and clinical judgement to choose the appropriate treatment.

In patients with moderate to severe covid-19, the body’s immune system may go into overdrive within a week to 10 days of initial symptoms, causing inflammation, which can lead to organ damage and death. Once tests confirm the so-called cytokine storm, doctors typically prescribe immunity-suppressing drug tocilizumab to prevent complications.

Thyrocare Technologies Ltd managing director A. Velumani said his diagnostic chain has reagent stocks for only three days for D-Dimer, C-reactive protein, ferritin and interleukin-6 (IL-6) tests which are used to check for cytokine storms.

“The new cases have come like a tsunami, and we were not prepared for it. I think the government should have invested resources in building capacity for these reagents last year, but we didn’t. Right now, we are importing these reagents from some manufacturers in Europe and Japan, and they prefer the dollar market over us. The only reason we have any supply left is because we are a large player and we are arm-twisting vendors to get us with preference,” Velumani said.

The scarcity of reagents, primarily imported from Roche Diagnostics, Siemens Healthineers and Abbott, adds to supply crunch in drugs and imported raw materials for vaccines.

“We are currently experiencing an exponential increase in demand for these reagents, in line with the sharp rise in cases,” said Narendra Varde, managing director for Roche Diagnostics’ India and neighbouring markets. He added that the Indian arm is working with its global and regional wings to expedite shipments and ensure prioritization of supplies to India.

Queries sent to Siemens Healthineers and Abbott were not answered at the time of publishing.

In the absence of these tests, doctors are forced to check for other symptoms like a rapid drop in oxygen levels with normal white blood cell count and imaging techniques like CT scan and X-Ray to check for cytokine storms.

“If I have to prescribe tocilizumab, then I will have to have IL6 markers and CRP levels. It certainly will help me in taking a decision at an appropriate time. These markers help in taking a decision quicker. Also, tocilizumab, which is used to treat cytokine storm, is an expensive therapy. I need to have these tests to convince the patient’s relatives that the drug is needed and work with them,” said Vikas Maurya, director and head of the department of pulmonology, chest and sleep medicine at Fortis Hospital in Delhi’s Shalimar Bagh.

Tocilizumab, which costs around ₹40,000 per dose and is imported solely by Cipla from Roche of Switzerland, is the only treatment under the government’s clinical management guidelines for cytokine storms. The drug also has been facing a shortage.

Vaccine makers are struggling to secure ingredients as well.

Key raw materials, including single-use consumables and clinical products such as quality-control reagents, single-use plastic bags, and filters are in short supply, said Sai Prasad, president of Developing Countries Vaccine Manufacturers Network and executive director of quality operations, Bharat Biotech International.

Vaccine makers outside the US are struggling to raise production after the US invoked the Defense Production Act (DPA) in February to restrict the export of key raw materials, industry executives said on Friday.

There is also the shortage of key drugs like remdesivir and favipiravir, but the crunch here is primarily due to manufacturing capacity not being able to meet the surge in demand. Remdesivir is manufactured by seven companies in India — Hetero Drugs, Zydus Cadila, Dr Reddy’s Laboratories, Cipla, Jubilant Pharma, Mylan and Syngene International — under a pact with the drug’s US-based innovator Gilead Sciences Inc. Syngene has also partnered with Sun Pharmaceutical Industries to contract-manufacture the drug.

Acknowledging the shortage, the government has sped up clearances for these companies to scale up capacity. According to a senior executive with one of the manufacturers, the time to produce these drugs has now reduced to 8-10 days from 15-20 earlier as regulators have shortened the time for clearances to determine sterility of the batches.